Patient non-compliance, or the fact that patients do not take their medication as prescribed, is a major problem for the pharmaceutical industry and society as a whole. It is estimated that in the United States 125,000 people die each year due to problems associated with patient non-compliance, and the cost of non-compliance for the health care insurance industry is as high as $100 billion annually, including 10% of hospital admissions at a cost of $15.2 billion (2001) and 23% of nursing home admissions at a cost of $31.3 billion (2001). The United States economy is also impacted, as medication non-compliance leads to an estimated loss of 20 million work days annually (corresponding to $1.5 billion in lost revenue for employers).
In the United States alone, the costs of non-compliance for pharmaceutical manufacturers exceed $30 billion in annual lost revenue. Improving patient compliance with prescription drug regimens would benefit all the parties in the health care sector, from the patients themselves to other major stakeholders: Medicare/Medicaid and other Health Management Organizations (HMOs) would benefit from the savings related to the reduction in hospital and nursing home admissions; drug manufacturers and pharmacies would benefit from the associated increase in drug sales; Pharmacy Benefit Management (PBM) organizations would benefit from increased bargaining power due to increased sales, improved revenues, and improved services to patients and other stakeholders; patients would experience better service, higher satisfaction, and increased safety by increasing medication compliance.
Various systems have been devised in an attempt to overcome the causes of patient non-compliance, including simple forgetfulness of patients. These systems have included watches and other wearable devices, boxes of special design, and electronic medication dispensers. However, previous systems have proven to be workable only in controlled environments and they have failed to address a number of the causes of patient non-compliance. Prior art systems have failed to satisfy at least three requirements that must be met if a patient reminder system is to be workable in large commercial settings.
First, a system must provide tangible benefits to the sponsors who pay for the system. Performance data collected by the system should demonstrate the financial benefits to potential sponsors and thus justify sponsor participation in the system. Under certain circumstances, funds from sponsors could be used to make the service free for the patients, which will in turn stimulate patient participation in the system.
Second, the system must engage the patient. The advantage of using health-care providers to set up medications reminders has been noted in the prior art, for instance, research has demonstrated that 25-50% of patient non-compliance is derived from patient forgetfulness. However, prior art systems have lacked incentive systems to keep the patient engaged in the service over time. Additionally, many prior art systems, such as pager-based systems, have allowed limited or no patient participation.
Third, the system must have a practical implementation. Most compliance solutions offer an abstract approach to the patient non-compliance problem. However, they do not address a critical question: how to reach a critical mass in the highly fragmented health care market. Critical mass is required to make the method profitable and ensure its survival in the long run. A system that does not tackle the issue of how to create a critical mass of pharmacies and patients adopting the system cannot be implemented, and is functionally useless.
Prior art systems have failed to address the highly regulated nature of the health care industry, including regulation under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Health care systems deal with sensitive patient information, and errors by these systems can lead to serious liability for service providers. For example, a service failure could cause a patient to improperly take or miss doses of medication. Hackers who compromise the system could obtain sensitive patient information. Any system that operates in the health care industry must be reliable and secure; otherwise, the risk of liability will prevent its adoption. Patient consent is a necessary part of such systems, and there is a need to define an effective security protocol to protect the system against external attack. Examples of security procedures that are required to allow the method to operate in a commercial setting are: authentication, encryption, firewalls, back-ups, and data protection mechanisms and procedures in case of catastrophic events.
Prior art systems do not allow a reminder service to be transferred between pharmacy chains. Several pharmacy chains (e.g., Duane Reade) do not have terminals integrated to exchange patient data. This means that the service may not be transferable among pharmacy branches. As patients may change pharmacy chains, be restricted by health care network membership due to their insurance or for other reasons, or choose mail order pharmacies to fill certain prescriptions, it is important that a service be portable and transferable.
Patient reminder alerts are likely to be set up at a point in time different from the time the patient picks up the prescription. Thus, an activation mechanism must be in place to ensure that the alert system is activated at the right time, which would normally be defined by the prescription pick-up time. There is a need in the prior art to specify an activation mechanism that takes this delay into account.
Any commercially viable reminder system must also be designed to allow high load of information input, storage and output. In order to provide high availability, servers must be mirrored and databases must be replicated.